Clinical Research Associate

4 weeks ago


Bedford, United States G&H Staffing Companies (Temp-Secure Staffing and LSE Staffing) Full time

Our client located in Bedford, MA is looking for a Clinical Research Associate to join their team on a direct hire basis. This role offers a hybrid work schedule.

Responsibilities:

  • Serve as primary in-house site contact through all phases of the clinical study from startup through close out activities including site selection, site qualification, site initiation, subject enrollment and follow-ups and close-out as required.
  • Regularly track and communicate study status to Study Team, Supervisor and Upper Management
  • Create study specific processes, clinical documentation trackers and guidance documents.
  • Assist in the review, editing, execution, submission and tracking of study documents for IRB Approval.
  • Assist in the review and editing of informed consents forms (ICF) and completion of the ICF checklist for final review by the Sr. Clinical Project Manager (PM).
  • Create and revise study specific materials, such as source worksheets, study specific training slide presentations and essential document templates as requested by study PM.
  • Manage and track the review and execution process for site contracts, contract amendments and budgets.

Experience:

  • Bachelor’s Degree and minimum 3 years clinical affairs related experience.
  • Experience with clinical operations as a CRA working on multiple studies from site selection through study close-out.
  • Experience working effectively in small cross-functional teams.
  • Proficient in the use and management of electronic TMF systems.
  • Proficient in Google Workspace/Microsoft Office (Word, Excel, PowerPoint), CTMS software and comfortable with EDC systems.
  • Knowledge of US Regulations, ISO standards, GCP, GDP, and ICH Guidelines


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